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The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
Recruiting
Trial ID: NCT03014401
Purpose
The purpose of this study is to compare the clinical and functional outcomes of patients with
mild to moderate arthroscopically confirmed osteoarthritis between the following two groups:
1. Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with
standard arthroscopic treatment consisting of: partial meniscectomy, cartilage
stabilization, loose body removal and selective synovectomy.
2. Standard arthroscopic treatment (above) without cell transplant.
Official Title
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial
Stanford Investigator(s)
Seth Lawrence Sherman, MD
Associate Professor of Orthopaedic Surgery
Eligibility
Inclusion Criteria:
- Age between 35 and 70 years-old
- Patient is scheduled to undergo one or a combination of the following procedures:
- Meniscal debridement or partial menisectomy
- Meniscal repair that does not necessitate a different postoperative protocol from
meniscal debridement or partial menisectomy
- Removal of loose bodies
- Chondroplasty
- Synovectomy
- Soft tissue releases for flexion or extension contracture.
- Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral
femoral condyle (Kellgren-Lawrence Grade 2 or 3)
- < 6 months of knee pain or < 6 months of a significant exacerbation of existing knee
pain
- Physical examination findings consistent with the proposed surgical procedure.
- Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy
and trial of anti-inflammatory medications, with or without concomitant bracing and/or
injections
Exclusion Criteria:
- Age < 35 or > 70 years old
- Radiographs demonstrating either no, little or severe osteoarthritis
(Kellgren-Lawrence Grade 0, 1 or 4)
- Previous injury or surgery to the infrapatellar fat pad (assessed by MRI)
- Patient scheduled to undergo any concomitant surgical procedures with the exception
of:
- Meniscal debridement or partial menisectomy
- Meniscal repair that does not necessitate a different postoperative protocol from
meniscal debridement or partial menisectomy
- Removal of loose bodies
- Chondroplasty
- Synovectomy
- Soft tissue releases for flexion or extension contracture
- Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture,
Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant
- Previous arthroscopy within 1 year
- Subchondral edema
Intervention(s):
procedure: Arthroscopic debridement with stem cell transplantation
procedure: Arthroscopic debridement only
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jason L Dragoo, MD